Clinical Comparative Study of Systematic Therapy Combined With MWA and Systematic Therapy for Pancreatic Cancer

NCT06231160 | Unknown

• 1 other identifier: 82171941
• Study Type: observational
• Target: 185
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.

Conditions

Pancreatic Neoplasms; Ablation

Outcome Measures

Primary Outcomes (1)

• overall survival

  Time from receiving treatment to death

  30, 90, and 180 days after the end of the last chemotherapy

Secondary Outcomes (1)

• Pain relief rate

  30, 90, and 180 days after the end of the last chemotherapy

Study Arms (2)

Systematic Therapy Combined With Microwave Ablation

Perform microwave ablation for patients with pancreatic cancer, and then conduct chemotherapy according to the guidelines two to three weeks later

Procedure: Systematic Therapy Combined With Microwave Ablation

Systematic Therapy

Using the same chemotherapy method as the experimental group

Interventions

Systematic Therapy Combined With Microwave Ablation PROCEDURE

Patients with unresectable pancreatic cancer were included for laboratory examination, and quality of life and pain scores were recorded. The experimental group underwent microwave ablation first, followed by chemotherapy according to the guidelines; The control group received the same chemotherapy. Record the use of chemotherapy drugs and the occurrence of adverse events. Follow up will be conducted at 30 days, 90 days, and 180 days after chemotherapy to evaluate pancreatic function and quality of life.

Also known as: Systematic Therapy

Systematic Therapy Combined With Microwave Ablation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pancreatic cancer

You may qualify if:

• Inoperable pancreatic cancer
• Age from 18 to 80
• PS score from 0 to 3
• Clear pathological diagnosis

You may not qualify if:

• Severe coagulation dysfunction
• Individuals with severe heart, lung, liver, and kidney dysfunction
• Individuals with acute or active infectious lesions in any part of the body
• Psychological health issues that hinder this experiment

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Related Publications (6)

• Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

  PMID: 36633525 BACKGROUND

• Kluger MD, Epelboym I, Schrope BA, Mahendraraj K, Hecht EM, Susman J, Weintraub JL, Chabot JA. Single-Institution Experience with Irreversible Electroporation for T4 Pancreatic Cancer: First 50 Patients. Ann Surg Oncol. 2016 May;23(5):1736-43. doi: 10.1245/s10434-015-5034-x. Epub 2015 Dec 29.

  PMID: 26714959 BACKGROUND

• Wang Z, Liu M, Zhang DZ, Wu SS, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Chen JA, Lin YC, Lu X, Wu YQ, Zhang XW, Zhang YF, Cheng C, Ye HL, Wang LT, Zhong HG, Zhong JH, Wang L, Chen M, Liang FF, Chen Y, Xu YS, Yu XL, Cheng ZG, Liu FY, Han ZY, Tang WZ, Yu J, Liang P. Microwave ablation versus laparoscopic resection as first-line therapy for solitary 3-5-cm HCC. Hepatology. 2022 Jul;76(1):66-77. doi: 10.1002/hep.32323. Epub 2022 Jan 28.

  PMID: 35007334 BACKGROUND

• Fegrachi S, Walma MS, de Vries JJJ, van Santvoort HC, Besselink MG, von Asmuth EG, van Leeuwen MS, Borel Rinkes IH, Bruijnen RC, de Hingh IH, Klaase JM, Molenaar IQ, van Hillegersberg R. Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study. Eur J Surg Oncol. 2019 Nov;45(11):2166-2172. doi: 10.1016/j.ejso.2019.06.008. Epub 2019 Jun 12.

  PMID: 31227340 BACKGROUND

• Martin RC 2nd, Kwon D, Chalikonda S, Sellers M, Kotz E, Scoggins C, McMasters KM, Watkins K. Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy. Ann Surg. 2015 Sep;262(3):486-94; discussion 492-4. doi: 10.1097/SLA.0000000000001441.

  PMID: 26258317 BACKGROUND

• Vogl TJ, Panahi B, Albrecht MH, Naguib NNN, Nour-Eldin NA, Gruber-Rouh T, Thompson ZM, Basten LM. Microwave ablation of pancreatic tumors. Minim Invasive Ther Allied Technol. 2018 Feb;27(1):33-40. doi: 10.1080/13645706.2017.1420664. Epub 2017 Dec 26.

  PMID: 29278340 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Ping Liang

  The Fifth Medical Center of the General Hospital of the PLA of China

  STUDY CHAIR

Central Study Contacts

Ping Liang

CONTACT

66939530; liangping301@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 30, 2024

Record last verified: 2024-01